DSH 411 General requirements

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DSH 411 0 H+ _( w$ P" A3 g4 d& |: W- q2 i

General requirements 9 R# {, Z7 }; B/ L9 X  \

20.1 8 K: E9 X' y% }6 _; q

60601-1(ed.2);am1;am2

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
/ [5 j3 v& T  }$ MSub clause(s): 20.1
$ e  T3 |/ {" B% ySheet n°: DSH-411
Subject: General requirements
0 X) M' t& X( k* L( nKey words: Leakage current, SIP/SOP, working voltage, A-k
; O6 }1 o8 S* c+ Z$ ?Confirmed by CTL at its 39th meeting, in Cologne
Question:
I) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
7 \. O0 d" g6 Y5 ^( |8 p7 x. P! Rfrom external sources, or both?
ii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which
ensures absence of excessive LEAKAGE CURRENTS not to be tested?
iii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
8 L2 p9 c' E# C! s4 y- C) ZSOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
% T9 b! w" e/ y5 f+ F$ M9 X9 wequipment be permitted, subject to some restrictions?
" u( @* ~" |- v6 D- _Decision:
4 ~1 g0 l2 r6 z7 u1 l  Oi) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
$ L% d' o. }/ O9 OEQUIPMENT consistent with the instructions for use.
$ S3 h/ r9 o( ^$ W  b. {7 A) Aii) b) applies to a SFC resulting from a single component failure within the SIP or SOP in
" C: s6 G* J! J! vNORMAL USE i.e. connected as specified in the instructions for use. If such a SFC does not
; F+ }$ M1 V2 e$ O$ Cproduce excessive LEAKAGE CURRENTS then no additional insulation test is needed.
# d4 P" k! m& m% I4 y& S5 }iii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL
8 @4 m# o) ~' A( {* ^0 e# XELECTRICAL EQUIPMENT
; ?6 D( x0 h5 Z8 ?- w0 \
7 ]9 o6 A: ?: M4 K* }